Combination study of deferasirox and erythropoietin in patients with low- and int-1-risk myelodysplastic syndrome.

An open-label, phase II, randomized, pilot study to assess the effect in term of erythroid improvement of deferasirox combined with erythropoietin compared to erythropoietin alone in patients with low- and int-1-risk myelodysplastic syndrome.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000981-12-SE

Enrollment

Registered

2013-06-24

Start date

2013-09-04

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

low- and int-1-risk myelodysplastic syndrome MedDRA version: 19.1 Level: LLT Classification code 10028534 Term: Myelodysplastic syndrome NOS System Organ Class: 100000004864

Interventions

Trade Name: Exjade Product Name: Exjade Product Code: ICL670 Pharmaceutical Form: Dispersible tablet INN or Proposed INN: DEFERASIROX CAS Number: 201530-41-8 Current Sponsor code: ICL670 Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with low- and Int-1-risk myelodysplastic syndrome ? Documented diagnosis of the following: ? Myelodysplastic syndrome lasting = 3 months and =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: ? Patients with MDS with isolated del(5q) ? Patients who had received prior EPO treatment or other recombinant growth factors regardless of the outcome (Patient who had received prior EPO treatment or other recombinant growth factors for less than 4 weeks and not within 3 months before screening without a documented response are allowed) ? Patients receiving steroids or immunosuppressive therapy for the improvement of hematological parameters (stable steroid treatment for adrenal failure or other chronic medical conditions, and intermittent dexamethasone as antimetic are allowed). ? B12 and folate deficient patients with or without clinical symptoms (patients could be rescreened after successful therapy of B12 and folate deficiency) ? Uncontrolled seizures or uncontrolled hypertension

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of treatment with DFX+EPO vs. EPO alone on erythropoiesis after 12 weeks of treatment defined by hemoglobin levels;Secondary Objective: Key secondary objective: To assess the effect of treatment with DFX + EPO and EPO alone on hematological response within 24 weeks of treatment Other secondary objectives as per protocol may apply.;Primary end point(s): Difference in proportion of patients achieving an erythroid response within 12 weeks of treatment between the two arms according to modified IWG 2006 criteria (increase in Hb = 1.5 g/dL);Timepoint(s) of evaluation of this end point: within 12 weeks	—

Measure

Time frame

Main Objective: To assess the effect of treatment with DFX+EPO vs. EPO alone on erythropoiesis after 12 weeks of treatment defined by hemoglobin levels;Secondary Objective: Key secondary objective: To assess the effect of treatment with DFX + EPO and EPO alone on hematological response within 24 weeks of treatment Other secondary objectives as per protocol may apply.;Primary end point(s): Difference in proportion of patients achieving an erythroid response within 12 weeks of treatment between the two arms according to modified IWG 2006 criteria (increase in Hb = 1.5 g/dL);Timepoint(s) of evaluation of this end point: within 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of patients achieving a hematological response within 24 weeks of treatment with DFX + EPO and EPO alone (increase in Hb, improvement of neutropenia and thrombocytopenia) according to modified IWG 2006 criteria.;Timepoint(s) of evaluation of this end point: within 24 weeks	—

Countries

Algeria, Argentina, Canada, China, Germany, Italy, Korea, Republic of, Spain, Sweden, United Kingdom, United States

Contacts

Public ContactMedical information

Novartis Sverige AB

medinfo@novartis.com+4687323200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026